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Hepatology

The decision to revoke the conditional marketing authorization is based on a June 2024 CHMP recommendation from the EMA suggesting the benefits of Ocaliva do not outweigh its risks.

European Commission Revokes Obeticholic Acid (Ocaliva) CMA for Primary Biliary Cholangitis

Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy had similar technical success, and failure with one method could be successfully cannulated with the other.

Salvage EUS-RV, Precut Sphincterotomy Comparable for Difficult Bile Duct Cannulation

Kumar explains what is known about the use of PPAR agonists in primary biliary cholangitis and the significance of the recent FDA accelerated approvals of elafibranor and seladelpar.

Sonal Kumar, MD, MPH: PPAR Agonists in PBC, Advances in Second-Line Therapy

In this video segment, Reau, Trivedi, and Hirschfield discuss pipeline developments and other advances in primary biliary cholangitis they are most looking forward to.

The Future of PBC Management, Pipeline Developments

In this video segment, Reau, Trivedi, and Hirschfield discuss how the emergence of second-generation PPAR agonists like seladelpar and elafibranor impact PBC management.

Impact of Next-Generation PPAR Agonists on PBC Management

In this video segment, Reau, Trivedi, and Hirschfield discuss how treatment sequencing in PBC has evolved over time with the emergence of new second-line therapies and considerations for determining sequencing.

Considerations for Treatment Sequencing in Primary Biliary Cholangitis

In this video segment, Reau, Trivedi, and Hirschfield discuss the EMA opinion on obeticholic acid and its impact on discussions about second-line therapies amid the influx of new treatment options available for patients.

Assessing PBC Treatment Options, Determining Sequencing

In this video segment, Reau, Trivedi, and Hirschfield discuss the availability of new second-line treatment options and their role in PBC management compared to traditional therapies like UDCA and OCA.

Recent Advances in Second-Line Therapies in PBC

In this video segment, Reau, Trivedi, and Hirschfield discuss recent shifts in treatment goals for patients with PBC and a new focus on timely intervention with second-line options.

Shifting Treatment Goals, Timelines in Primary Biliary Cholangitis

The accelerated approval is based on phase 3 data demonstrating seladelpar’s impact on ALP reduction and is contingent upon verification and description of clinical benefit in confirmatory trial(s).

FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!